uk medical covid 19 test diagnostic kit sale product specifications

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  • Guidance on legislation Guidance on the ... - GOV.UK

    2021-8-7 · SELFCheck COVID-19 Antigen Test – pack of 2. A simple and reliable lateral flow test for the detection of COVID-19 antigens from a nasal swab sample. Unlike most tests provided by the UK Department for Health and NHS, these are a commercial alternative, designed and certified specifically for self testing. For example, our SELFCheck test only ...

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  • Q&A on in vitro diagnostic medical device conformity ...

    Test kits for Sars-CoV-2 (COVID-19) BIOHIT HealthCare Ltd now distributes test kits from Immundiagnostik AG and Genetic Analysis AS to help the fight against Coronavirus in the UK. . Test kits for the diagnosis of current and past COVID-19 (Sars-CoV-2) infection by real time RT-PCR for swabs and stool, and antibody tests for anti-SARS-CoV-2 IgG.

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  • TARGET PRODUCT PROFILE - GOV.UK

    The AlphaBiolabs COVID-19 Antigen (Ag) Rapid Test is one of the world’s first rapid screening tests for the identification of the COVID-19 (SARS-CoV-2), from 14 days after initial exposure to the virus and or after the onset of symptoms. There is no laboratory testing required, instead results are available in just 15 – 30 minutes via the ...

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  • REGULATORY REQUIREMENTS FOR COVID-19 RAPID

    COVID-19 Testing Coronavirus Diagnostic Laboratory Equipment. Coronaviruses are single-stranded RNA viruses that belong to the Coronaviridae family. It is the emergence of the most current coronaviruses, SARS-CoV-2 (the virus responsible for the disease Covid-19), which has the research community’s attention.

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  • Q&A on in vitro diagnostic medical device conformity ...

    2021-6-28 · COVID-19 tests - Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19 5 The manufacturer’s information accompanying RUO products must explicitly state that they are for research use only, and they must not have instructions regarding diagnosis or other medical use, which

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  • REGULATORY REQUIREMENTS FOR COVID-19 RAPID

    A complete COVID-19 product portfolio of CE-marked diagnostic tests to support the fight against the pandemic: Laboratory RT-PCR test for COVID-19: Dedicated platforms for the full automation of Real Time PCR IVD tests, including RNA extraction, PCR plate steup, full sample tracing, for SARS-CoV-2 detection and variant identification.

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  • TARGET PRODUCT PROFILE - GOV.UK

    COVID-19 IgM/IgG Rapid Test. Medakit has developed and launched one of the world’s first rapid point-of-care lateral flow immunoassays for the diagnosis of coronavirus infection. The test has been used widely by the Chinese CDC to combat infections and is now available globally. This test detects both early marker and late marker, IgM/IgG ...

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